Washed Microbiota Transplantation for Malnutrition
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- change of weight and height
研究概览
简要总结
Malnutrition is a pathological condition in which dietary intake fails to meet the body's energetic or nutritional needs. It may be caused by macronutrient or micronutrient deficiencies, high energy expenditure, impaired nutrient absorption or assimilation. Malnutrition can affect all stages of life. In adults, malnutrition is strongly associated with poor clinical outcomes such as increased morbidity, increased mortality and prolonged hospitalization. In children, malnutrition can lead to growth retardation, cognitive impairment and immune dysfunction.
详细描述
The gut microbiota of malnourished patients is different from that of healthy people. The diversity of the gut microbiota of patients with severe malnutrition reduced and the abundance of Proteobacteria significantly increased, as well as pathogenic genera such as Klebsiella, Escherichia coli, Shigella, and Streptococcus. This suggests that gut microbiota plays an important role in the occurrence and development of malnutrition. Dietary intervention targeting gut microbiota can quickly improve children's malnutrition, promote weight gain and increase protein levels that promote bone growth and nerve development. Exclusive enteral nutrition combined with immediate washed microbiota transplantation(WMT) can rapidly improve the nutritional status of patients with Crohn's disease compared with those with delayed WMT. Gut microbiota has been confirmed to be closely related to malnutrition. Improving the disordered gut microbiota in malnourished patients may become a potential treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old;
- •Meet any of the following two conditions: ①weight loss (>5% weight loss in the past 6 months or >10% weight loss in more than 6 months); ②low BMI (<70 years old and BMI<18.5kg/m2 or ≥70 years old and BMI<22kg/m2);
- •Underwent washed microbiota transplantation.
排除标准
- •Expected survival time <3 months;
- •Women who are pregnant or breastfeeding;
- •Other patients deemed not suitable for enrollment by the investigator.
结局指标
主要结局
change of weight and height
时间窗: baseline, 4 weeks, 8 weeks, 12 weeks post transplantation
Weight and height will be combined to report BMI in kg/m\^2.
change of the third lumbar vertebrae skeletal muscle mass and height
时间窗: baseline, 12 weeks post transplantation
The third lumbar vertebrae skeletal muscle mass represents the sum of the cross-sectional areas of the skeletal muscles at the L3 level, including the psoas major, the erector spinae, the quadratus lumborum, the musculus transversus abdominis, the obliquus externus abdominis and the obliquus internus abdominis. Skeletal muscle mass and height will be combined to report the third lumbar vertebrae skeletal muscle mass index(L3 SMI) in cm\^2/m\^2.
次要结局
- change of the Pittsburgh Sleep Quality Index (PSQI)(baseline, 4 weeks, 8 weeks, 12 weeks post transplantation)
- change of insulin-like growth factor I(IGF-I)(baseline, 12 weeks post transplantation)
- the difference of the gut microbiota composition before and after washed microbiota transplantation(baseline, 12 weeks post transplantation)
- change of the 5-level EuroQoL Group's 5-dimension (EQ-5D-5L)(baseline, 4 weeks, 8 weeks, 12 weeks post transplantation)
- change of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)(baseline, 4 weeks, 8 weeks, 12 weeks post transplantation)
- change of the Gastrointestinal Symptom Rating Scale(GSRS)(baseline, 4 weeks, 8 weeks, 12 weeks post transplantation)
- the incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0(12 weeks post transplantation)
研究者
Faming Zhang
Professor, Gastroenterology
The Second Hospital of Nanjing Medical University